HealthyPhase 1NCT03673527
Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin
A Phase 1 study testing topical formulation of tacrolimus in people with Healthy, run by LEO Pharma at 1 site in Germany.
Trial summary
This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- topical formulation of tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 22 Nov 2018to 11 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between 18 and 60 years of age, with a body mass index (BMI) between 18.5 and 30 kg/m2 inclusive
- Female subjects of childbearing potential must be confirmed not pregnant at the screening visit and use highly effective contraception during the trial.
Who cannot join
- Treatment with the following medications: Topical immunosuppressive drugs (e.g. tacrolimus, corticosteroids), systemic immunosuppressive/immunomodulating drugs
- Extensive UV radiation or sunlight on the application sites
- Skin diseases
- Wounded or damaged skin at the application site
- Immunosuppressed or immunocompromised individuals
- Renal or hepatic impairment or insufficiency
- Known allergy or known or suspected hypersensitivity to any component(s) of the topical formulation of tacrolimus
- Female subjects who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-randomised, Single-centre, Multiple-dose, Phase 1, Pharmacokinetic Trial With a Topical Formulation of Tacrolimus in Healthy Subjects
This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.
Read the detailed description
The purpose of this trial is to assess the safety of a topical formulation of tacrolimus.
Tacrolimus is commonly used in T-cell medicated diseases. It is expected that 24 subjects will be enrolled in the trial and will be assigned to receive topical application of tacrolimus twice daily for 14 days.
- Conditions
- Healthy
- Being tested
- topical formulation of tacrolimus
- Keywords
- open-label, multiple-dose, non-randomised, non-comparative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical formulation of tacrolimusDrug
Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).
| Study group | Role | What they receive |
|---|---|---|
| topical formulation of tacrolimus | Experimental | Not described Receives: Drug: topical formulation of tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14
Measured: Up to Day 14
Maximum Observed Drug Concentration (Cmax) of tacrolimus
Measured: On Days 1 and 14
Secondary outcomes (10)
Number of adverse events (AEs) up to Day 21
Measured: Day -22 to Day 21
Number of subjects with AEs up to Day 21
Measured: Day -22 to Day 21
Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Measurement unit: mmHg
Measured: Day 1 to Day 21
Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Measurement unit: bpm
Measured: Day 1 to Day 21
Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Measurement unit: °C
Measured: Day 1 to Day 21
Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation
Measurement unit: mmHg
Measured: Day 1 to Day 21
Changes in pulse from baseline to Day 21 summarised by mean and standard deviation
Measurement unit: bpm
Measured: Day 1 to Day 21
Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation
Measurement unit: °C
Measured: Day 1 to Day 21
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14
Measured: Day 1 to Day 14
Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start22 Nov 2018
- Primary completion4 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673527
- Sponsor's protocol ID
- LP0121-1388
- Other IDs
- 2018-001959-12, 2018
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2018
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomised, Single-centre, Multiple-dose, Phase 1, Pharmacokinetic Trial With a Topical Formulation of Tacrolimus in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03673527
- Acronym / sponsor ID
- LP0121-1388
- Conditions
- Healthy
- Keywords
- open-label, multiple-dose, non-randomised, non-comparative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.
Detailed description
The purpose of this trial is to assess the safety of a topical formulation of tacrolimus.
Tacrolimus is commonly used in T-cell medicated diseases. It is expected that 24 subjects will be enrolled in the trial and will be assigned to receive topical application of tacrolimus twice daily for 14 days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| topical formulation of tacrolimus | Experimental | Drug: topical formulation of tacrolimus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects between 18 and 60 years of age, with a body mass index (BMI) between 18.5 and 30 kg/m2 inclusive
- Female subjects of childbearing potential must be confirmed not pregnant at the screening visit and use highly effective contraception during the trial.
Key exclusion criteria (8 listed)
- Treatment with the following medications: Topical immunosuppressive drugs (e.g. tacrolimus, corticosteroids), systemic immunosuppressive/immunomodulating drugs
- Extensive UV radiation or sunlight on the application sites
- Skin diseases
- Wounded or damaged skin at the application site
- Immunosuppressed or immunocompromised individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical formulation of tacrolimusTopical application of tacrolimus twice daily for 14 days (one dose on Day 14). | Drug | topical formulation of tacrolimus |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14
Time frame: Up to Day 14
Maximum Observed Drug Concentration (Cmax) of tacrolimus
Time frame: On Days 1 and 14
10 secondary outcomes
Number of adverse events (AEs) up to Day 21
Time frame: Day -22 to Day 21
Number of subjects with AEs up to Day 21
Time frame: Day -22 to Day 21
Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Time frame: Day 1 to Day 21
Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Time frame: Day 1 to Day 21
Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Time frame: Day 1 to Day 21
Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation
Time frame: Day 1 to Day 21
Changes in pulse from baseline to Day 21 summarised by mean and standard deviation
Time frame: Day 1 to Day 21
Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation
Time frame: Day 1 to Day 21
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14
Time frame: Day 1 to Day 14
Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14
Time frame: Day 1 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topical formulation of tacrolimus in people with Healthy, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14 (time frame: Up to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.